Cleared Special

K982293 - PRESSURE TRANSDUCER AIRFLOW SENSOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K982293 · Pro-Tech Services, Inc. · Anesthesiology device
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Jul 1998
Decision
12d
Days
Class 2
Risk

K982293 is an FDA 510(k) clearance for the PRESSURE TRANSDUCER AIRFLOW SENSOR. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Woodinville, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pro-Tech Services, Inc. devices

Submission Details

510(k) Number K982293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date July 13, 1998
Days to Decision 12 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 139d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.